PRESENTATION ON IN-

PLANT TRAINING

Square Pharmaceuticals Limited

Dhaka unit
Content
 Introduction & history
 Human Resource Department (HRD)
 Production Planning & Inventory Control (PPIC)
 Warehouse
 Formulation Unit
 GPB

 SVPO

 Insulin & MDI

 LVP

 Cephalosporin
Content
 Square Formulation Lab (SFrL)
 Quality Control (QC)
 Quality Assurance (QA)
 Microbiology
 Regulatory affairs
 Research & Development (R&D)
 Engineering Department
Introduction & history
 Square group of companies
 1958 - Square pharmaceuticals LTD

 1968 - transformed into Private Limited Company

 1974 – partnership with Janssen Pharmaceuticals, Belgium

which turned SPL into a company with latest technology

 1982 – license agreement with F. Hoffman-La Roche

Limited
 1987 – exported pharmaceutical products for the first time

 1988 – introduced Square Toiletries Limited

 1994 – became Public Limited Company

  2000-03 – introduced Square Knit fabrics limited, fashion, consumer
products, information limited & lastly Square Hospital Limited
 Achievements
 2007- gets the UK MHRA approval
 2012- gets the TGA of Australia approval
 2015- obtains pre-approval from FDA to export Valsartan to USA
 Other then these fascinating achievements SPL have been awarded loads
of silverwares for their quality, policy, strategy and not to mention their
mission, vision and objectives.
The great mind

Mr. Samson H
Chowdhury (1925-
2012)
“We named it SQUARE
because it was started by
four friends and also
because it signifies
accuracy and perfection
meaning quality”
Human Resource Department (HRD)
 Set of individuals
 Human Capital
 Official function
 Liaison with Corporate head quarter
 Guest entertainment
 Factory visit for outsiders

Improved
Improved HR
HR Improved
Improved employee
employee Improved
Improved customer
customer Regular
Regular income
income for
for the
the
Regular
Regular customer
customer
performance
performance satisfaction
satisfaction satisfaction
satisfaction company
company
HRD
 HRD activities overview

HR

Developm
Developm
ent
ent and
and
counseling
counseling

Working
Working Internal
Internal
environ
environ commu
commu
ment
ment nication
nication

Personal
Personal
Trainin
producti
producti
g vity
vity
Reward
Reward
and
and
retainmen
retainmen
tt
 PPIC
 Requisition of raw and packaging materials
 Sales trend
 Climate
 Environment
 Season etc.

Production RM at
Sales forcast Depot stock Requisition SCM Receive
target warehouse
PPIC

 Lead time
 Local 45 days
 Imported 90 days (min.)
 Packaging material 25 days
 Production schedule
 Regular manufacturing
 Toll manufacturing
 Capacity planning
 SAP (Systems Applications and Production in-data
processing)
Monitoring and control -

PPIC

QC Distribution

PMD/IMD
Warehouse Forecast
sharing

SCM
Production Material
procurement
Warehouse
 Types
 Raw material warehouse
 Finished goods warehouse
 Segments
 Marshal area
 Sampling booth
 Warehouse
 Racks for RM
 Racks for PM
 Racks for QIR
 Racks for damaged material
 Cold storage
 Airlock
Warehouse
 Labels used
QUARANTINED

SAMPLED

PASSED

REJECTED

 Finished goods warehouse

Raw Finished
material Productio goods
warehous n unit warehous
e e
General Production Building (GPB)
 Change Procedure
 Manufacturing
 Dispensing
 Dispensing procedure
 Cleaning
 Production
 Tablet
 Granulation
 Blending
 Compression
 Coating
GPB
 Encapsulation
 Empty capsule shell
 Powder blend or pellets
 Filling
 Enclosing of cap and body
 Ejection
 Packaging
 Primary packaging
 Secondary packaging
GPB machineries

Categories Machines
Granulator Eurovent, Yenchen, GEA
Wet & dry mill Quadro mill
Fluid bed dryer Eurovent
Compression Korch 300, PTK, BWI Manesty (Rota-press and
uni-press)
Coating IMA, PAM-GLATT, Gansons 1200 & 1500
Encapsulation Bosch, Sejong
Packaging Blister (HEINO-ILSEMANN, HONGA Minister V-
6, Noack 920 & 921)
Strip (SOLPAC)
Container (Yoosung filling system)
Cephalosporin unit
 Facility
 Products
 Machines
Categories Machines
Sieving and mixing Yenchen, Piller Hoist
Drying PAM GLATT FBD 250,
Milling GLATT ROTOR mill
Blending Yenchen drum blender
Slugging and compression Yenchen, Sejong GRC 15S
Coating NR coater
Capsule filling MACOFAR CD40
Vial filling Romaco DS
Vial capping and sealing MACOFAR CSP 10
Primary packaging Blister (IMA, HOONGA, )
Small volume parenteral & ophthalmic unit

 Purpose
 Facility
 Class A, B, C & D
 HVAC
 HEPA filters
 Autoclave
 CIP
 SIP
 BFS
 Products
 BFS ear drop, BFS eye drop, Nebulizer solution
 Machines
 Telstar flexicon filling machine (Denmark)
 Airtech LV (Germany)
 Weiler BFS machine (USA)
 Flumatex filling machine (Germany)
 Critical process parameters
 Formulation
 Filling
 Adjustment of pH
Insulin & MDI unit

 CFC free MDI project

 Manufacturing
 Dispensing (class c)
 Formulation (class c)
 Premix
 Sterilizing filtration (pH 2.5-3)
 Crystallization
 Filling
 Products
 Insulin R
 Insulin N
 Mixed (N+R)
Insulin & MDI unit
 MDI components
 Canister
 Metering valve
 Actuator (mouth piece)
 Product concentrate
 Filling process

Product filling Valve setting crimping HFA introduction Weight checking

Machines

Insulin MDI
Autoclave celester Cansorter
IMA-MAC filling and Micronizer
washing machine Valve sorter
Dabrico OCS weightchecker
Bausch + Strobel Shrink wrapper
cartridge filling and
washing unit
Large volume parenteral unit
 Facility
 Floor 1
 BFS line, BAG line, Nasal line, Amino acid line
 Floor 2
 Ampoule line (SVP), BFS formulation line, prefilled syringe line, Vial & lyophilized
product line
 Machines
 Fedegari - autoclave machine
 Tofflon - ampoule washing, depyrogenation, filling & sealing
 Rommelag – BFS filling, deflashing, cap welding
 Trueking – vial filling and labeling
 HOONGA - blister packaging
LVP
Dosage forms Terminal Aseptic filling
sterilization
LVP filled bottles by BFS Yes No
technology
LVP bottle type vial Yes yes
LVP bag Yes Yes
SVP ampoule Yes Yes
SVP prefilled syringe Yes
Nasal spray Non sterile
Amino acid n/a n/a
Square Formulations Lab (SFrL)
 Features
 Spacious
 Uni-directional man and material flow
 Tablets and capsules only
 Dedicated warehouse
 Dedicated effervescent tableting area
 Own QC lab
 Dedicated API dispensing booth
Machines

category machines No.

Granulator COS.mec 7 (2)
Blender 3 (1)
Tablet press Fette 11 (3)
Coating machine Pam 6 (3)
Encapsulation Sejong 1
Blister packaging Hoong-A
Strip packaging Solpac 1
Quality Control department (QC)
A part of quality management focused on fulfilling quality
requirements.
 Organization
 Raw material
 Finished goods
 Packaging materials
 Water analysis
 Raw material testing
 Appearance
 Identification
 Assay
 Impurities & related substances etc
 Packaging material testing
 • Finished goods testing

SVPO INSULIN MDI TABLET CAPSULE

Appearance Appearance Appearance Appearance Appearance

Identification Identification Identification hardness Identification

pH pH Leakage test Thickness Uniformity of

weight
Assay Potency Uniformity of Diameter DT
delivered dose
Osmolarity Related Deposition of DT Dissolution
compounds emitted dose
Uniformity of Crystal Related Dissolution Assay
filled volume characters substances
Sterility test Percent of stated Assay Friability Microbial test
dose
Quality Assurance department (QA)
Refers to the systematic activities implemented in a quality system,
so that quality requirements for a product or service is fulfilled
 Quality parameters
 GMP
 Appropriate, qualified and trained personnel
 Easy cleaning and easy pest control
 Written instructions
 Developing and revising SOPs
 Developing and revising BMRs
 Others
 Change control system
 Suitable equipments
 Customer complain
 Raw materials
QA
 Template of APQR (Annual Product Quality Report)
 Review of starting and packaging materials
 Finished product test results
 Investigations
 Failed batch
 Non-conformance
 Changes of analytical methods
 Process related changes
 Analytical method related changes
 Marketing authorization variations
 Post marketing commitments
 Review of technical agreements
 Review of previous APQR report
Stability-

long term ●

●
Temp → 250c
RH → 65%
Frequency of the test : After every 3 months gap →1st year, then
stability test
●

after every 6 months gap →second year and lastly with 1 year gap.

Intermediate ●

●
Temp → 300c
RH → 65%
stability test ●
Frequency of the test : 0,3,6,9 months

Accelerated ●

●
Temp → 400c
RH → 75%
stability test ●
Frequency of the test : 0,1,2,3 and 6th month
 Stability test parameters for solid dosage forms –
 Appearance change
 Dissolution test
 Disintegration test
 Potency test
 Impurity test
 Microbial test
 Hardness test
Microbiology
 Duties
 Water test
 Chemical tests
 Microbial tests
 LAL test
 Microbiological test for non sterile dosage forms
 Microbiological tests for raw and packaging materials
 Microbial assay of antibiotics
 Performing validation etc.
 Clean room status
 Scope
 Microbiological tests for FU-1, FU-2 & FU-3
 Regulatory affairs
 Goal of regulatory affairs
 Protection of human health
 Ensuring safety, efficacy & quality of drugs
 Ensuring appropriateness & accuracy of
product information
 Dossier
 CTD (common technical document)
 Modules
 1: administrative info. & prescribing info.
 2: summary of modules 3-5
 3: quality
 4: non-clinical study reports
 5: clinical study reports
 Research & Development department (R&D)

 Sections
 Galenical wing (PD)
 Analytical wing (MDV)
 R&D
 Product development (PD)
 Method development & validation (MDV)
 Accuracy
 Precision (repeatability & ruggedness)
 Specificity
 Robustness
 Sensitivity
 System suitability
 R&D
 LVP & bio-similar lab
Engineering department
 Responsibility
 Providing power
 Maintaining HVAC system
 Providing water treatment
 ETP maintenance
 Maintenance of manufacturing equipments and machines
 HVAC
 AHU (air handling unit)
 Chiller (4)
 Dehumidifier (6)
 Pre-filter
 HEPA filter
Water treatment system

Multimedia Reserve
Raw water
tank tank

Activated
carbon filter
Softer tank

One micron Feed water Reverse

filter storage tank osmosis

Degasser
EDI unit

UV storage
ETP (Effluent Treatment Plant )

Screen Equalizatio Alum & NaOH

chamber n tank solution tank

Clari- Poly-electrolyte
flocculator tank solution tank

Aeration Clarifier Holding

tank tank tank

Activated
carbon filter
Sand filter

Filter press
Thank you
Presentation given by-
 Ahmed Sabbir
 Joy Chandra Rajbangshi
 Md Ariful Islam
 Proshanto Shaha